Notice2026-19232
Esther Villanueva Valdes, M.D.; Decision and Order
Primary source
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Published
September 21, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 91 Issue 181 (Monday, September 21, 2026)</title>
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[Federal Register Volume 91, Number 181 (Monday, September 21, 2026)]
[Notices]
[Pages 59798-59800]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19232]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Esther Villanueva Valdes, M.D.; Decision and Order
On February 19, 2025, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Esther Villanueva
Valdes, M.D., of Arecibo, Puerto Rico (Registrant). Request for Final
Agency Action (RFAA), Exhibit (RFAAX) 1, at 1, 4. The OSC proposed the
revocation of Registrant's Certification of Registration No. BV4657485,
alleging that Registrant is ``currently without authority to . . .
handle controlled substances in the Commonwealth of Puerto Rico, the
U.S. territory in which [she is] registered with DEA'' and has been
mandatorily excluded from participation in Medicare, Medicaid, and all
Federal health care programs pursuant to 42 U.S.C. 1320a-7(a). Id. at 2
(citing 21 U.S.C. 824(a)(3), (5)).\1\
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\1\ According to the OSC and Agency records, Registrant's
registration expired on May 31, 2025. RFAAX 1, at 2. The fact that a
registrant allows his or her registration to expire during the
pendency of an administrative enforcement proceeding does not impact
the Agency's jurisdiction or prerogative under the Controlled
Substances Act to adjudicate the OSC to finality. Jeffrey D. Olsen,
M.D., 84 FR 68474, 68476-79 (2019).
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The OSC notified Registrant of her right to file a written request
for hearing, and that if she failed to file such a request, she would
be deemed to have waived her right to a hearing and be in default. Id.
at 3 (citing 21 CFR 1301.43). Here, Registrant did not request a
hearing, and the Agency finds her to be in default. RFAA, at 3.\2\ ``A
default, unless excused, shall be deemed to constitute a waiver of the
registrant's/applicant's right to a hearing and an admission of the
factual allegations of the [OSC].'' 21 CFR 1301.43(e).
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\2\ Based on the Government's submissions in its RFAA dated
February 12, 2026, the Agency finds that service of the OSC on
Registrant was adequate. The RFAA's included Declaration from a DEA
Diversion Investigator (DI) indicates that on February 24, 2025, the
DI emailed the OSC to Registrant and on that same day Registrant
acknowledged receipt of the OSC via email. RFAAX 2, at 1; see id.,
Attachment A. Here, the Agency finds that Registrant was
successfully served the OSC by email.
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Further, ``[i]n the event that a registrant . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' Id. at 1301.43(f)(1). Here, the
Government has requested final agency action based on Registrant's
[[Page 59799]]
default pursuant to 21 CFR 1301.43(c), (f), and 1301.46. RFAA, at 4;
see 21 CFR 1316.67.\3\
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\3\ The RFAA states that ``the Administrator is authorized to
render the Agency's final order, without holding a hearing or making
findings of fact in this matter.'' RFAA, at 3-4 (citing 21 CFR
1301.43(c), (f), and 1301.46). However, 21 CFR 1316.67 requires that
the Administrator's final order ``set forth the final rule and
findings of fact and conclusions of law upon which the rule is
based.'' See JYA LLC d/b/a Webb's Square Pharmacy, 90 FR 31244,
31246 n.7 (2025).
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I. Loss of State Authority
A. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
According to the OSC, Registrant's Puerto Rico medical license, issued
by the Puerto Rico Board of Medical Licensure and Discipline (Board),
expired on July 4, 2022. RFAAX 1, at 2. Registrant also held a Board
controlled substance license that expired on August 31, 2023. Id.
According to Puerto Rico online records, of which the Agency takes
official notice,\4\ Registrant's medical license is expired and remains
in such status. Commonwealth of Puerto Rico Department of Health,
Division of Board of Licensing and Medical Discipline Verification
Search, <a href="https://orcps.salud.pr.gov/mbps/verificacion">https://orcps.salud.pr.gov/mbps/verificacion</a> (last visited date
of signature of this Order). Accordingly, the Agency finds that
Registrant is not licensed to practice medicine in Puerto Rico, the
jurisdiction in which she is registered with DEA.\5\
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\4\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979).
\5\ Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision
rests on official notice of a material fact not appearing in the
evidence in the record, a party is entitled, on timely request, to
an opportunity to show the contrary.'' The material fact here is
that Registrant, as of the date of this Order, is not licensed to
practice medicine in Puerto Rico. Accordingly, Registrant may
dispute the Agency's finding by filing a properly supported motion
for reconsideration of findings of fact within fifteen calendar days
of the date of this Order. Any such motion and response shall be
filed and served by email to the other party and to the Office of
the Administrator, Drug Enforcement Administration, at
<a href="/cdn-cgi/l/email-protection#87e3e2e6a9e6e3e3e8a9e6f3f3e8f5e9e2fef4c7e3e2e6a9e0e8f1"><span class="__cf_email__" data-cfemail="3a5e5f5b145b5e5e55145b4e4e5548545f43497a5e5f5b145d554c">[email protected]</span></a>.
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B. Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under 21 U.S.C. 823 ``upon a
finding that the registrant . . . has had his State license or
registration suspended . . . [or] revoked . . . by competent State
authority and is no longer authorized by State law to engage in the . .
. dispensing of controlled substances.'' With respect to a
practitioner, DEA has also long held that the possession of authority
to dispense controlled substances under the laws of the state in which
a practitioner engages in professional practice is a fundamental
condition for obtaining and maintaining a practitioner's registration.
See, e.g., James L. Hooper, M.D., 76 FR 71371, 71372 (2011), pet. for
rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton,
M.D., 43 FR 27616, 27617 (1978).\6\
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\6\ This rule derives from the text of two provisions of the
Controlled Substances Act (CSA). First, Congress defined the term
``practitioner'' to mean ``a physician . . . or other person
licensed, registered, or otherwise permitted, by . . . the
jurisdiction in which he practices . . . , to distribute, dispense,
. . . [or] administer . . . a controlled substance in the course of
professional practice.'' 21 U.S.C. 802(21). Second, in setting the
requirements for obtaining a practitioner's registration, Congress
directed that ``[t]he Attorney General shall register practitioners
. . . if the applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he practices.'' 21
U.S.C. 823(g)(1). Under the CSA, the term ``state'' means ``a State
of the United States, the District of Columbia, and any
commonwealth, territory, or possession of the United States,''
including Puerto Rico. 21 U.S.C. 802(26). Because Congress has
clearly mandated that a practitioner possess authority in order to
be deemed a practitioner under the CSA, DEA has held repeatedly that
revocation of a practitioner's registration is the appropriate
sanction whenever he is no longer authorized to dispense controlled
substances under the laws of the jurisdiction in which he practices.
See, e.g., James L. Hooper, 76 FR at 71371-72; Sheran Arden Yeates,
M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR
51104, 51105 (1993); Bobby Watts, M.D., 53 FR 11919, 11920 (1988);
Frederick Marsh Blanton, 43 FR at 27617.
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According to the Puerto Rico Controlled Substances Act, ``[a]ny
person who manufactures, distributes and dispenses controlled
substances in the Commonwealth of Puerto Rico . . . shall obtain a
registration certification annually, issued by the Secretary of Health,
pursuant to the rules and regulations approved and promulgated by said
government official.'' P.R. Laws Ann. tit. 24, Sec. 2302(a) (current
through all acts translated by the Translation Office of the Puerto
Rico Government through the 2025 Legislative Session). Further,
``dispense'' means ``the prescribing, administering or delivering of a
controlled substance to an ultimate user, by prescription or order for
administering it. It includes the process of the compounding, labeling
and packaging of a controlled substance for such delivery. The term
`dispenser' means the practitioner who so delivers a controlled
substance.'' Id. Sec. 2102(11).
Here, the undisputed evidence in the record is that Registrant
lacks authority to dispense controlled substances in Puerto Rico. As
discussed above, an individual must hold a controlled substance license
and be licensed to practice medicine to dispense a controlled substance
in Puerto Rico. Thus, because Registrant lacks authority to handle
controlled substances in Puerto Rico, Registrant is not eligible to
maintain a DEA registration in that jurisdiction. Accordingly, the
Agency will order that Registrant's DEA registration be revoked.
Registrant's lack of state authority to handle controlled
substances in Puerto Rico is sufficient by itself to support revoking
Registrant's DEA registration. Infra n.9. The following mandatory
exclusion ground provides an additional, independent basis for revoking
Registrant's DEA registration.
II. Mandatory Exclusion From Federal Health Care Programs
A. Findings of Fact
Registrant is deemed to admit that on April 7, 2021, in the United
States District Court for the District of Puerto Rico, Registrant pled
guilty to one count of healthcare fraud in violation of 18 U.S.C. 1347
and judgment was entered against her on August 30, 2021.\7\ RFAAX 1, at
2. As a result of Registrant's guilty plea and criminal conviction, the
U.S. Department of Health and Human Services, Office of Inspector
General (HHS/OIG), mandatorily excluded Registrant from participation
in Medicare, Medicaid, and all Federal health care programs, effective
March 20, 2022, for a minimum period of 8 years, pursuant to 42 U.S.C.
1320a-7(a). Id.
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\7\ See United States v. Esther Villanueva-Valdes, No. 3:21-cr-
00101-ADC (D.P.R.).
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B. Discussion
Pursuant to 21 U.S.C. 824(a)(5), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the CSA
upon finding that the registrant ``has been excluded (or directed to be
excluded) from participation in a program pursuant to section 1320a-
7(a) of Title 42.'' The Agency has consistently held that it may also
deny an application upon finding that an applicant has been excluded
from a federal health care program. Mark Agresti, M.D., 90 FR 30098,
30099 (2025); Samirkumar Shah, M.D., 89 FR 71931, 71933 (2024);
Arvinder Singh, M.D., 81 FR 8247, 8248 n.3 (2016).
The Agency finds substantial record evidence that Registrant has
been, and
[[Page 59800]]
remains, mandatorily excluded from federal health care programs
pursuant to 42 U.S.C. 1320a-7(a).\8\ Accordingly, the Agency finds that
substantial record evidence establishes the Government's prima facie
case for revocation of Registrant's registration under 21 U.S.C.
824(a)(5).
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\8\ The underlying conviction forming the basis for mandatory
exclusion from participation in federal health care programs need
not involve controlled substances to provide the grounds for
revocation or denial pursuant to Section 824(a)(5). Jeffrey Stein,
M.D., 84 FR 46968, 46971-72 (2019); Narciso Reyes, M.D., 83 FR
61678, 61681 (2018); KK Pharmacy, 64 FR 49507, 49510 (1999)
(collecting cases).
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III. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Registrant's registration should be revoked, the burden
shifts to Registrant to show why she can be entrusted with a
registration. Morall v. Drug Enf't Admin., 412 F.3d. 165, 174 (D.C.
Cir. 2005); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin.,
881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR
18882 (2018). The issue of trust is necessarily a fact-dependent
determination based on the circumstances presented by the individual
practitioner. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see Jones
Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past
performance is the best predictor of future performance, DEA
Administrators have required that a registrant who has committed acts
inconsistent with the public interest must accept responsibility for
those acts and demonstrate that the registrant will not engage in
future misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833;
ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995).
Historically, the Agency has considered acceptance of responsibility,
egregiousness, and deterrence when making this assessment. See Michael
Bouknight, 90 FR 31247, 31250 (2025); Sasha Melissa Ikramelahai, 90 FR
32017, 32020-21 (2025); Frank Joseph Stirlacci, M.D., 85 FR 45229,
45239-40 (2020).
The Agency requires a registrant's unequivocal acceptance of
responsibility. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024);
Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see Jones Total Health
Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's candor
during the investigation and hearing, if one is requested, is an
important factor in determining acceptance of responsibility and the
appropriate sanction. See Jones Total Health Care Pharmacy, 881 F.3d at
830-31; Hoxie v. Drug Enf't Admin., 419 F.3d 477, 483-84 (6th Cir.
2005). Further, the Agency has found that the egregiousness and extent
of the misconduct are significant factors in determining the
appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at 833
n.4, 834. The Agency also considers the need to deter similar acts by a
registrant and by the community of registrants. Jeffrey Stein, M.D., 84
FR at 46972-73.
Here, Registrant did not timely request a hearing or answer the
allegations in the OSC and was deemed to be in default. To date,
Registrant has not filed a motion with the Office of the Administrator
to excuse the default. 21 CFR 1301.43(c)(1). Registrant has thus failed
to properly answer the allegations contained in the OSC and has not
otherwise availed herself of the opportunity to refute the Government's
case. As such, Registrant has not accepted responsibility for the
proven violations, has made no representations regarding her future
compliance with the CSA, and has not demonstrated that she can be
trusted with registration.
Accordingly, the Agency will order the revocation of Registrant's
registration.\9\
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\9\ In this matter there are two separate and distinct grounds
by which the Government proposed revocation, Registrant's lack of
state authority and her mandatory exclusion; each ground, standing
alone, supports the Agency's decision to revoke.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
BV4657485, issued to Esther Villanueva Valdes, M.D. Further, pursuant
to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
823(g)(1), I hereby deny any pending applications of Esther Villanueva
Valdes, M.D., to renew or modify this registration, as well as any
other pending application of Esther Villanueva Valdes, M.D., for
additional registration in Puerto Rico. This Order is effective October
21, 2026.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 11, 2026, by DEA Administrator Terrance C. Cole. That
document with the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-19232 Filed 9-18-26; 8:45 am]
BILLING CODE 4410-09-P
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